PTSDNCT04563741
MOVE!+UP: Testing a Tailored Weight Management Program for Veterans With PTSD
A study testing MOVE!+UP and MOVE! in people with PTSD and Overweight, run by VA Office of Research and Development at 1 site in United States.
Trial summary
Posttraumatic Stress Disorder (PTSD) is common among Veterans and results in poor psychological functioning, quality of life, and physical health. This includes having disproportionately high rates of obesity, in part due to PTSD symptoms interfering with physical activity and healthy diet. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PTSD, Overweight, Obesity
- What is being tested?
- MOVE!+UP and MOVE!
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 174 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2020to 26 Mar 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- PTSD Diagnosis: standard criteria for PTSD Checklist for DSM-5 (PCL-5): lifetime experience of trauma and a score of 33
- Overweight or obesity based on Body Mass Index (BMI) of 25 kg/m2
- Primary Care Provider or other physician approval
- Willing to participate in all intervention or control and assessment activities
- Enrolled in PTSD treatment
- Must have active VA Puget Sound Health Care System medical record.
Who cannot join
- Not fluent in English, severe hearing loss, no phone access
- Current MOVE! participation
- Current pregnancy
- Based on clinical judgment, would be unable to participate because of:
- acutely exacerbated substance use, mental health, or chronic medical conditions
- or moderate to severe chronic, progressive neurologic conditions such as Dementia
Show all 9Show fewer
- had bariatric surgery within the last 12 months or plan to undergo bariatric surgery within the next 6 months.
- Report they cannot safely weigh themselves using the mailed study scale due to mobility issues or use of assistive devices
- Baseline weight >440 lbs
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Seattle, Washington, 98108-1532
About this study
Posttraumatic Stress Disorder (PTSD) is common among Veterans and results in poor psychological functioning, quality of life, and physical health. This includes having disproportionately high rates of obesity, in part due to PTSD symptoms interfering with physical activity and healthy diet. Unfortunately, Veterans with PTSD have poorer weight loss outcomes than those without PTSD in VA's existing weight management program, MOVE!. Based on pilot work, it appears that a weight management program that augments standard PTSD care and targets PTSD-related barriers to weight loss improves weight and PTSD symptoms. Whether it improves these issues more than standard VA care is in need of study, which is the focus of the proposed research. The proposed study also seeks to understand factors that would interfere with and facilitate implementing the program in VA if it is effective. This Veteran-centered, tailored weight loss program may efficiently benefit both physical and mental health of Veterans with PTSD, addressing standard care limitations.
Read the detailed description
Background: Post-traumatic stress disorder (PTSD), prevalent among Veterans, puts Veterans at increased risk for obesity and related conditions. Veterans with PTSD lose less weight in VA's MOVE! weight management program, due to PTSD symptoms that interfere with activity and healthy diet. In addition, many Veterans who receive evidence-based PTSD treatment remain symptomatic. A behavioral weight loss program that augments standard PTSD care and targets PTSD-related weight loss barriers called MOVE!+UP was piloted and iteratively refined among 44 overweight Veterans with PTSD. The fully developed MOVE!+UP is led by a psychologist and a Veteran peer support counselor, who provide complementary expertise. It includes 16 group sessions with 90 minutes of general weight loss support, coupled with Cognitive Behavior Therapy skills to address PTSD-specific barriers. Each session also includes a 30-minute community walk to address hypervigilance-based activity barriers and enhance classroom-based learning. Veterans receive two individual dietician visits, and counseling calls as needed. The cohort receiving the final MOVE!+UP package reported high satisfaction and had better weight loss outcomes than Veterans with PTSD in the general MOVE! program. They also reported substantial PTSD symptom reduction. Treatment targets like eating behaviors, activity, and insomnia also improved. MOVE!+UP effectiveness must be tested in a randomized trial.
Significance/Impact: MOVE!+UP is timely and efficient, simultaneously addressing physical and mental health of a priority Veteran group. MOVE!+UP is positioned to address HSR\&D priorities by promoting mental health and improving PTSD symptoms, access to care, and whole health. This study is aligned with HSR\&D and ORD methodological priorities by using a hybrid type 1 trial. This study's cost and utilization analyses, and systematic identification of implementation barriers and facilitators, would place effectiveness findings in context and facilitate rapid translation to the field if MOVE!+UP is effective. This study will also provide insights about ways that general MOVE! and PTSD care can be enhanced to improve reach and effectiveness.
Innovation: MOVE!+UP is the first weight loss program designed to address obesity in Veterans with PTSD.
Specific Aims: This study proposes to enroll Veterans with PTSD who are classified as overweight or with obesity and who are engaged in PTSD care. They will be randomized to usual care enhanced with MOVE! (control) or usual care enhanced with MOVE!+UP (intervention), and is guided by three aims: 1) Test whether intervention participants have greater 6-month weight loss (primary outcome), and 6- and 12-month PTSD symptom reduction and 12-month weight loss (secondary exploratory outcomes), relative to controls; 2) Assess whether compared to control, intervention participants have greater improvements on 6-month treatment targets: physical activity, eating behavior, insomnia, depression, and social support; 3) Estimate intervention and control condition costs and utilization, and identify MOVE!+UP implementation barriers and facilitators, to contextualize Aim 1 and inform future implementation.
Methodology: Hybrid type 1 trial with 164 Veterans with PTSD who are classified as overweight or with obesity and are currently enrolled in PTSD care.
Implementation/Next Steps: This hybrid type 1 trial will provide data needed to prepare a MOVE!+UP implementation package for broader VA implementation if MOVE!+UP is effective. If it is not effective, Aims 2 and 3 will help understand how overweight Veterans with PTSD could be better supported in the future. Implementation activities would be coordinated with existing local, VISN, and national operational partners.
- Conditions
- PTSD, Overweight, Obesity
- Being tested
- MOVE!+UP, MOVE!
- Medical subject headings
- Stress Disorders, Post-Traumatic, Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MOVE!+UPBehavioural
behavioral weight management intervention developed for Veterans with PTSD
MOVE!Behavioural
standard VA weight management intervention
| Study group | Role | What they receive |
|---|---|---|
| MOVE!+UP (intervention) | Experimental | usual care enhanced with MOVE!+UP (intervention) Receives: Behavioral: MOVE!+UP |
| MOVE! (control condition) | Active comparator | usual care enhanced with MOVE! (control condition) Receives: Behavioral: MOVE! |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight (Pounds) Change From Baseline to 6 Months Post-baseline
This study's primary aims is to test whether intervention participants have greater 6-month weight loss, relative to controls.
Measured: baseline and 6 months post-baseline
Secondary outcomes (3)
Weight (Pounds) Change From Baseline to 12 Months Post-baseline
Test whether intervention participants have greater long-term (12-month) weight loss, relative to controls.
Measured: baseline and 12 months post-baseline
PTSD Symptom Severity on the PTSD Checklist for DSM-5 Change From Baseline to 6 Months Post-baseline
Assess whether compared to control, intervention participants have greater improvements on 6-month PTSD symptom severity. Total scores range 0 - 80, where higher scores are indicative of greater severity.
Measured: baseline and 6 months post-baseline
PTSD Symptom Severity on the PTSD Checklist for DSM-5 Change From Baseline to 12 Months Post-baseline
Assess whether compared to control, intervention participants have greater improvements on 12-month PTSD symptom severity. Total scores range 0 - 80, where higher scores are indicative of greater severity.
Measured: baseline and 12 months post-baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2020
- Study start1 Oct 2020
- Primary completion26 Mar 2025
- Study completion26 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PTSDStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a hybrid type 1 trial with Veterans with PTSD who are classified as overweight or with obesity, and who are currently enrolled in PTSD care. Participants will be randomized to usual care enhanced with MOVE! (control) or usual care enhanced with MOVE!+UP (intervention).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 174 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Katherine D Hoerster, PhD MPH BA, Principal investigator, VA Puget Sound Health Care System Seattle Division, Seattle, WA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04563741
- Sponsor's protocol ID
- IIR 18-230
- Other IDs
- HX002755-01A2
- Status last verified
- May 2026
- First submitted
- 8 Sep 2020
- Last updated
- 6 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hoerster KD, Tanksley L, Sulayman N, Bondzie J, Brier M, Damschroder L, Coggeshall S, Houseknecht D, Hunter-Merrill R, Monty G, Saelens BE, Sayre G, Simpson T, Wong E, Nelson K. Testing a tailored weight management program for veterans with PTSD: The MOVE! + UP randomized controlled trial. Contemp Clin Trials. 2021 Aug;107:106487. doi: 10.1016/j.cct.2021.106487. Epub 2021 Jun 16.
PubMed 34144246Hoerster KD, Sulayman N, Hunter-Merrill R, Coggeshall S, Tanksley L, Brier M, Donovan L, Fennell T, Gray K, Evans DH, Rosendahl K, Saelens BE, Simpson T, Nelson KM. Enhanced Weight Management Program for Veterans With Posttraumatic Stress Disorder: A Randomized Clinical Trial. JAMA Netw Open. 2026 Mar 2;9(3):e261904. doi: 10.1001/jamanetworkopen.2026.1904.
PubMed 41893847
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MOVE!+UP: Testing a Tailored Weight Management Program for Veterans With PTSD
- ClinicalTrials.gov ID
- NCT04563741
- Acronym / sponsor ID
- IIR 18-230
- Conditions
- PTSD, Overweight, Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 174 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 26 Mar 2025 (actual)
- Study completion
- 26 Mar 2025 (actual)
- First posted
- 24 Sep 2020 (actual)
- Results
- Posted 6 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Posttraumatic Stress Disorder (PTSD) is common among Veterans and results in poor psychological functioning, quality of life, and physical health. This includes having disproportionately high rates of obesity, in part due to PTSD symptoms interfering with physical activity and healthy diet. Unfortunately, Veterans with PTSD have poorer weight loss outcomes than those without PTSD in VA's existing weight management program, MOVE!. Based on pilot work, it appears that a weight management program that augments standard PTSD care and targets PTSD-related barriers to weight loss improves weight and PTSD symptoms. Whether it improves these issues more than standard VA care is in need of study, which is the focus of the proposed research. The proposed study also seeks to understand factors that would interfere with and facilitate implementing the program in VA if it is effective. This Veteran-centered, tailored weight loss program may efficiently benefit both physical and mental health of Veterans with PTSD, addressing standard care limitations.
Detailed description
Background: Post-traumatic stress disorder (PTSD), prevalent among Veterans, puts Veterans at increased risk for obesity and related conditions. Veterans with PTSD lose less weight in VA's MOVE! weight management program, due to PTSD symptoms that interfere with activity and healthy diet. In addition, many Veterans who receive evidence-based PTSD treatment remain symptomatic. A behavioral weight loss program that augments standard PTSD care and targets PTSD-related weight loss barriers called MOVE!+UP was piloted and iteratively refined among 44 overweight Veterans with PTSD. The fully developed MOVE!+UP is led by a psychologist and a Veteran peer support counselor, who provide complementary expertise. It includes 16 group sessions with 90 minutes of general weight loss support, coupled with Cognitive Behavior Therapy skills to address PTSD-specific barriers. Each session also includes a 30-minute community walk to address hypervigilance-based activity barriers and enhance classroom-based learning. Veterans receive two individual dietician visits, and counseling calls as needed. The cohort receiving the final MOVE!+UP package reported high satisfaction and had better weight loss outcomes than Veterans with PTSD in the general MOVE! program. They also reported substantial PTSD symptom reduction. Treatment targets like eating behaviors, activity, and insomnia also improved. MOVE!+UP effectiveness must be tested in a randomized trial.
Significance/Impact: MOVE!+UP is timely and efficient, simultaneously addressing physical and mental health of a priority Veteran group. MOVE!+UP is positioned to address HSR\&D priorities by promoting mental health and improving PTSD symptoms, access to care, and whole health. This study is aligned with HSR\&D and ORD methodological priorities by using a hybrid type 1 trial. This study's cost and utilization analyses, and systematic identification of implementation barriers and facilitators, would place effectiveness findings in context and facilitate rapid translation to the field if MOVE!+UP is effective. This study will also provide insights about ways that general MOVE! and PTSD care can be enhanced to improve reach and effectiveness.
Innovation: MOVE!+UP is the first weight loss program designed to address obesity in Veterans with PTSD.
Specific Aims: This study proposes to enroll Veterans with PTSD who are classified as overweight or with obesity and who are engaged in PTSD care. They will be randomized to usual care enhanced with MOVE! (control) or usual care enhanced with MOVE!+UP (intervention), and is guided by three aims: 1) Test whether intervention participants have greater 6-month weight loss (primary outcome), and 6- and 12-month PTSD symptom reduction and 12-month weight loss (secondary exploratory outcomes), relative to controls; 2) Assess whether compared to control, intervention participants have greater improvements on 6-month treatment targets: physical activity, eating behavior, insomnia, depression, and social support; 3) Estimate intervention and control condition costs and utilization, and identify MOVE!+UP implementation barriers and facilitators, to contextualize Aim 1 and inform future implementation.
Methodology: Hybrid type 1 trial with 164 Veterans with PTSD who are classified as overweight or with obesity and are currently enrolled in PTSD care.
Implementation/Next Steps: This hybrid type 1 trial will provide data needed to prepare a MOVE!+UP implementation package for broader VA implementation if MOVE!+UP is effective. If it is not effective, Aims 2 and 3 will help understand how overweight Veterans with PTSD could be better supported in the future. Implementation activities would be coordinated with existing local, VISN, and national operational partners.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This is a hybrid type 1 trial with Veterans with PTSD who are classified as overweight or with obesity, and who are currently enrolled in PTSD care. Participants will be randomized to usual care enhanced with MOVE! (control) or usual care enhanced with MOVE!+UP (intervention).
| Arm | Type | Receives |
|---|---|---|
| MOVE!+UP (intervention) | Experimental | Behavioral: MOVE!+UPusual care enhanced with MOVE!+UP (intervention) |
| MOVE! (control condition) | Active comparator | Behavioral: MOVE!usual care enhanced with MOVE! (control condition) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- PTSD Diagnosis: standard criteria for PTSD Checklist for DSM-5 (PCL-5): lifetime experience of trauma and a score of 33
- Overweight or obesity based on Body Mass Index (BMI) of 25 kg/m2
- Primary Care Provider or other physician approval
- Willing to participate in all intervention or control and assessment activities
- Enrolled in PTSD treatment
Key exclusion criteria (9 listed)
- Not fluent in English, severe hearing loss, no phone access
- Current MOVE! participation
- Current pregnancy
- Based on clinical judgment, would be unable to participate because of:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MOVE!+UPbehavioral weight management intervention developed for Veterans with PTSD | Behavioural | MOVE!+UP (intervention) |
| MOVE!standard VA weight management intervention | Behavioural | MOVE! (control condition) |
Primary outcome
Weight (Pounds) Change From Baseline to 6 Months Post-baseline
Time frame: baseline and 6 months post-baseline
This study's primary aims is to test whether intervention participants have greater 6-month weight loss, relative to controls.
3 secondary outcomes
Weight (Pounds) Change From Baseline to 12 Months Post-baseline
Time frame: baseline and 12 months post-baseline
PTSD Symptom Severity on the PTSD Checklist for DSM-5 Change From Baseline to 6 Months Post-baseline
Time frame: baseline and 6 months post-baseline
PTSD Symptom Severity on the PTSD Checklist for DSM-5 Change From Baseline to 12 Months Post-baseline
Time frame: baseline and 12 months post-baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 34144246Hoerster KD, Tanksley L, Sulayman N, Bondzie J, Brier M, Damschroder L, Coggeshall S, Houseknecht D, Hunter-Merrill R, Monty G, Saelens BE, Sayre G, Simpson T, Wong E, Nelson K. Testing a tailored weight management program for veterans with PTSD: The MOVE! + UP randomized controlled trial. Contemp Clin Trials. 2021 Aug;107:106487. doi: 10.1016/j.cct.2021.106487. Epub 2021 Jun 16.
- Derived from this study: PubMed 41893847Hoerster KD, Sulayman N, Hunter-Merrill R, Coggeshall S, Tanksley L, Brier M, Donovan L, Fennell T, Gray K, Evans DH, Rosendahl K, Saelens BE, Simpson T, Nelson KM. Enhanced Weight Management Program for Veterans With Posttraumatic Stress Disorder: A Randomized Clinical Trial. JAMA Netw Open. 2026 Mar 2;9(3):e261904. doi: 10.1001/jamanetworkopen.2026.1904.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katherine D Hoerster, PhD MPH BA principal investigator
VA Puget Sound Health Care System Seattle Division, Seattle, WA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MOVE!+UP and MOVE! in people with PTSD and Overweight, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight (Pounds) Change From Baseline to 6 Months Post-baseline (time frame: baseline and 6 months post-baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04563741, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.